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Neurologic Manifestations of the Arbovirus Infection in Colombia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03206541
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : February 20, 2020
Universidad del Valle, Colombia
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This is a multi-center case-control study that aims to define the association between the exposure to an arbovirus infection and the development of a neurological syndrome in patients from Colombia. The study makes part of the Neurovirus Emerging in the Americas Study (NEAS) that is a collaborative effort that looks to combine the efforts of researchers, healthcare providers and patients in Colombia to establish a comprehensive registry of the clinical, radiological and laboratory profile of patients with new onset of neurological diseases associated mosquito-borne viruses, known as arboviruses.

Condition or disease
Encephalitis Myelitis Guillain-Barre Syndrome Cranial Nerve Palsies Meningitis Zika Virus Infection Dengue (Virus); Fever, Sandfly Chikungunya Fever

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Study Type : Observational [Patient Registry]
Actual Enrollment : 570 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Neurovirus Emerging in the Americas Study (NEAS): Neurologic Manifestations of the Arbovirus Dengue, Chikungunya and Zika Infections in Colombia
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

The cases are defined as individuals that present with new onset of a neurological syndrome of unknown etiology, including but not limited to encephalitis, myelitis, meningitis, polyneuropathy/Guillain-Barre syndrome and cranial nerve involvement.

There are two age-matched control groups:

  1. Household controls that have lived with the case for at least three months before the onset of neurological symptoms.
  2. Controls with a febrile syndrome of unknown etiology that do not present neurological involvement and is recruited in the same center as the case.

Primary Outcome Measures :
  1. Neurological outcomes in arbovirus infections [ Time Frame: 12-24 months ]
    Number of patients with neurological syndromes that have evidence of acute infection by Zika, Dengue or Chikungunya viruses assessed by IgM serology or polymerase chain reaction

Secondary Outcome Measures :
  1. Viral genotype [ Time Frame: 24-36 months ]
    Number of strains of Zika, Dengue and Chikungunya viruses assessed by genome sequencing

  2. Immune response [ Time Frame: 24-36 months ]
    Cellular immune response assessed by T-lymphocyte profiling in patients with confirmed arbovirus infection with and without neurological syndromes

Biospecimen Retention:   Samples With DNA
The study will retain blood (serum and plasma), urine, spinal fluid and saliva for cases and controls according to the protocol. The samples will remain in the core laboratory at UV and some of them will be shared with the JHU team.

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population includes males and females over 8 years of age at risk of being infected by Dengue, Chikungunya or Zika viruses.

Inclusion Criteria:

  • Male or female
  • Case or control definition
  • Informed consent or assent

Exclusion Criteria:

  • Known etiology for the acute neurological disorders
  • History of known neurological syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03206541

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Clinica Leon XIII
Medellín, Antioquia, Colombia
Medellín, Antioquia, Colombia
Clinica La Misericordia Internacional
Barranquilla, Atlantico, Colombia
Clinica Medilaser
Neiva, Huila, Colombia
Hospital Universitario de Neiva
Neiva, Huila, Colombia
Hospital Universitario de Narino
Pasto, Narino, Colombia
Hospital Universitario Erasmo Meoz
Cúcuta, Norte De Santander, Colombia
Hospital Universitario del Valle
Cali, Valle Del Cauca, Colombia
Sponsors and Collaborators
Johns Hopkins University
Universidad del Valle, Colombia
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Principal Investigator: Carlos A Pardo-Villamizar, MD Johns Hopkins University
Principal Investigator: Beatriz Parra, PhD Universidad del Valle
Principal Investigator: Lyda Osorio, PhD Universidad del Valle
Additional Information:

Study Data/Documents: Suplemental Data  This link exits the site
This data set contains detailed information on a cohort of 68 cases with Guillain-Barre syndrome that was analyzed as part of NEAS. The NEAS forms used to collect clinical information are available at the end of the document.

Publications of Results:
Other Publications:
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Responsible Party: Johns Hopkins University Identifier: NCT03206541    
Other Study ID Numbers: IRB00093149
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NEAS is part of the ZikaPLAN, which is a consortium led by the European Community. There is a plan of sharing information with other collaborators within the consortium. The information will include demographic information, laboratory results and neurological physical exam. No identifiers will be shared. The information will be obtained through the ongoing recruitment of patients. We plan to share the first set of information during the second semester of 2017.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Neurological syndromes
Arbovirus infection
Additional relevant MeSH terms:
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Communicable Diseases
Chikungunya Fever
Zika Virus Infection
Arbovirus Infections
Guillain-Barre Syndrome
Neurologic Manifestations
Cranial Nerve Diseases
Virus Diseases
Body Temperature Changes
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases
Alphavirus Infections
Togaviridae Infections
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases